The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00744497




Registration number
NCT00744497
Ethics application status
Date submitted
29/08/2008
Date registered
1/09/2008
Date last updated
17/10/2016

Titles & IDs
Public title
Randomized Study Comparing Docetaxel Plus Dasatinib to Docetaxel Plus Placebo in Castration-resistant Prostate Cancer
Scientific title
A Randomized Double-Blind Phase 3 Trial Comparing Docetaxel Combined With Dasatinib to Docetaxel Combined With Placebo in Castration-Resistant Prostate Cancer
Secondary ID [1] 0 0
2008-000701-11
Secondary ID [2] 0 0
CA180-227
Universal Trial Number (UTN)
Trial acronym
READY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostatic Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Dasatinib
Treatment: Drugs - Docetaxel
Treatment: Drugs - Prednisone

Placebo Comparator: Placebo - Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily

Active Comparator: Dasatinib - Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily


Treatment: Drugs: Placebo


Treatment: Drugs: Dasatinib


Treatment: Drugs: Docetaxel


Treatment: Drugs: Prednisone


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival: Time From Randomization to Date of Death - Overall survival is defined as time in months from the randomization date to the date of death due to any cause (in the randomized population). If the patient did not die, survival was censored on the last date he or she was known to be alive.
Timepoint [1] 0 0
From randomization to death or date of last contact (maximum reached: 45 months)
Secondary outcome [1] 0 0
Percentage of Participants With an Objective Tumor Response by Modified Response Evaluation Criteria in Solid Tumors (RECIST) - Objective tumor response rate=the percentage of randomized participants with a best tumor response of partial (PR) or complete response (CR), within 42 days of end of dosing, divided by total number of patients who were evaluable (with at least 1 target lesion at baseline). By RECIST: CR=disappearance of clinical and radiologic evidence of target and nontarget lesions confirmed by another evaluation at least 6 weeks later. PR=a >30% or greater decrease in the sum of longest diameter (LD) of target lesions in reference to the baseline sum LD confirmed by another evaluation at least 6 weeks later. Stable disease=neither sufficient increase to qualify for PD nor shrinkage to qualify for PR, and at least 8 weeks since start of study therapy. Progressive disease=a 20% or greater increase in sum of LD of all target lesions, taking as reference the smallest sum of LD at or following baseline, or unequivocal progression on existing nontarget lesions, or new lesions are present.
Timepoint [1] 0 0
At baseline and every 12 weeks thereafter to end of treatment, at end of treatment, and at follow-up (within 42 days of end of dosing)
Secondary outcome [2] 0 0
Time to First Skeletal-related Event (SRE) - Time to first SRE is defined as the time in months from the date of randomization to the date of first SRE (unless SRE occurred while the patient was undergoing subsequent cancer therapy). Participants with a first SRE while on subsequent cancer therapy, those who died without a reported SRE, and those who did not have an SRE were censored on the date of their last SRE assessment prior to start of subsequent cancer therapy, if any. Participants who had no SRE assessments were censored on the day they were randomized.
Timepoint [2] 0 0
From day of randomization to date of first SRE or to last SRE assessment, if subsequent cancer therapy begun or no SRE (maximum reached: 42 months)
Secondary outcome [3] 0 0
Percentage of Participants With A Reduction in Urinary N-telopeptide (uNTx) Level From Baseline - The percentage of participants who had an on-study uNTx value confirmed (at least 3 weeks later) within normal limits (or =3 and <60 nmol/mmol creatinine, if normal limits were missing) or an on-study uNTx level reduction from baseline of =35%, even when on-study uNTx value remained abnormal.
Timepoint [3] 0 0
At baseline, prior to each docetaxel infusion (every 3 weeks) to end of treatment, at end of treatment, and at follow-up (within 14 days of end of dosing)
Secondary outcome [4] 0 0
Progression-free Survival (PFS) - PFS is defined as the time from the randomization date until the date of earliest evidence of disease progression or death, for participants who progressed or died before subsequent cancer therapy. Those who progressed or died while on subsequent cancer therapy and those who did not die or progress were censored at their last radiologic bone scan/imaging, skeletal related-event, or tumor assessment or at measurement of prostate specific antigen levels, whichever occurred last prior to start of subsequent cancer therapy ,if any. Participants with no assessments were censored on the day of randomization.
Timepoint [4] 0 0
From day of randomization to disease progression or death (or to last clinical assessment, if subsequent cancer therapy started or no progression or death) (maximum reached: approximately 43 months)
Secondary outcome [5] 0 0
Time to Prostate Specific Antigen (PSA) Progression - PSA progression is defined as the time from randomization to the date of the first PSA level measurement that led to confirmed PSA progression, for participants who had not started subsequent cancer therapy. For participants who did not progress or who progressed on cancer therapy, PSA progression is defined as the time from randomization to the date of the last PSA level measurement before the start of cancer therapy, if any. Participants who had no on-study PSA level measurements were censored on the day they were randomized.
Timepoint [5] 0 0
From randomization to date of first PSA measurement leading to confirmed PSA progression (or to last bone scan assessment, if no progression or if cancer therapy started) (maximum reached: 30 months)
Secondary outcome [6] 0 0
Percentage of Participants With a Reduction in Pain Intensity From Baseline - The percentage of participants with a reduction in pain intensity from baseline was defined as the number of participants who achieved a 30% or more decrease in pain intensity from baseline for at least 2 consecutive pain assessments (at least 14 days apart) within 14 days of end of dosing divided by the number of randomized participants who had a baseline pain intensity of at least 2. Pain intensity was assessed based on question 3 of the brief pain inventory questionnaire.
Timepoint [6] 0 0
At baseline, prior to each docetaxel infusion (every 3 weeks), at end of treatment, and at follow-up (within 14 days of end of dosing)

Eligibility
Key inclusion criteria
- History of histologically diagnosed prostate cancer

- Evidence of metastatic disease by any 1 of the following: computed tomography scan,
magnetic resonance imaging, bone scan, or skeletal survey

- Evidence of progression, as defined by 1 of the following: rising prostate specific
antigen levels at least 1 week apart with the final value being >=2 ng/mL; progression
of measurable nodal or visceral disease, with nodal lesions >=20 mm and visceral
lesions measurable per response evaluation criteria for solid tumors (Response
Evaluation in Solid Tumors, version 1); 2 or more lesions appearing on bone scan
compared with previous scan; or local recurrence in the prostate or prostate bed

- Maintaining castrate status: Participants who have not undergone surgical orchiectomy
should have received and continue on medical therapies, such as gonadotropin releasing
hormone analogs, to maintain castrate levels of serum testosterone <=50 ng/dL

- Eastern Cooperative Oncology Group Performance Status of 0 to 2

- At least 4 weeks since an investigational agent prior to starting study therapy

- At least 8 weeks since radioisotope therapy prior to starting study therapy

- Recovery from any local therapy including surgery or radiation/radiotherapy for a
minimum of 7 days prior to starting study therapy

- Required initial laboratory values: white blood cell count >=3,000/mm^3; absolute
neutrophil count >=1,500/mm^3; platelet count >=100,000/mm^3; creatinine level
<=1.5*upper limit of normal (ULN); bilirubin <=ULN; aspartate aminotransferase
<=2.5*ULN; alanine aminotransferase <=2.5*ULN.
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Symptomatic brain metastases or leptomeningeal metastases

- Clinically significant cardiovascular disease, including myocardial infarction;
ventricular tachyarrhythmia within 6 months; prolonged QTc >450 msec; ejection
fraction <40%; or major conduction abnormality, unless a cardiac pacemaker is present

- Pleural or pericardial effusion of any Common Terminology Criteria (CTC) grade

- Peripheral neuropathy CTC Grade >=2

- Currently active second malignancy other than nonmelanoma skin cancers. Participants
are not considered to have a currently active malignancy if they have completed
therapy and are now considered (by their physician) to be at less than 30% risk for
relapse

- Uncontrolled intercurrent illness including ongoing or active infection, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- HIV infection-positive patients receiving combination antiretroviral therapy

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to the investigational agents

- Receipt of any other investigational agents for the treatment of prostate cancer

- Prior cytotoxic chemotherapy in the metastatic setting, with the exception of
estramustine

- Patients may continue on a daily multivitamin but must discontinue all other herbal,
alternative, and food supplements before enrollment

- Ketoconazole must be discontinued 4 weeks prior to starting study therapy

- Antiandrogens must be discontinued prior to starting study therapy. Patients with a
history of response to an antiandrogen and subsequent progression while on that
antiandrogen should be assessed for antiandrogen withdrawal response for 4 weeks.
Observation for antiandrogen withdrawal response is not necessary for those who have
never responded to antiandrogens

- Bisphosphonates must not be initiated within 28 days prior to starting study therapy

- QT prolonging agents strongly associated with torsade de pointes.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Coffs Harbour
Recruitment hospital [2] 0 0
Local Institution - Lismore
Recruitment hospital [3] 0 0
Local Institution - Port Macquarie
Recruitment hospital [4] 0 0
Local Institution - Sydney
Recruitment hospital [5] 0 0
Local Institution - Douglas
Recruitment hospital [6] 0 0
Local Institution - Milton
Recruitment hospital [7] 0 0
Local Institution - Kurralta Park
Recruitment hospital [8] 0 0
Local Institution - Hobart
Recruitment hospital [9] 0 0
Local Institution - Frankston
Recruitment hospital [10] 0 0
Local Institution - Ringwood
Recruitment hospital [11] 0 0
Local Institution - Fremantle
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
2480 - Lismore
Recruitment postcode(s) [3] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [4] 0 0
2076 - Sydney
Recruitment postcode(s) [5] 0 0
4814 - Douglas
Recruitment postcode(s) [6] 0 0
4164 - Milton
Recruitment postcode(s) [7] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [8] 0 0
7000 - Hobart
Recruitment postcode(s) [9] 0 0
3199 - Frankston
Recruitment postcode(s) [10] 0 0
3135 - Ringwood
Recruitment postcode(s) [11] 0 0
6162 - Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Alaska
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Maine
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Mississippi
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Oregon
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
Rhode Island
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Washington
Country [23] 0 0
United States of America
State/province [23] 0 0
Wisconsin
Country [24] 0 0
Argentina
State/province [24] 0 0
Buenos Aires
Country [25] 0 0
Argentina
State/province [25] 0 0
Rio Negro
Country [26] 0 0
Argentina
State/province [26] 0 0
Santa Fe
Country [27] 0 0
Argentina
State/province [27] 0 0
Tucuman
Country [28] 0 0
Argentina
State/province [28] 0 0
Cordaba
Country [29] 0 0
Brazil
State/province [29] 0 0
Bahia
Country [30] 0 0
Brazil
State/province [30] 0 0
Rio Grande Do Sul
Country [31] 0 0
Brazil
State/province [31] 0 0
Sao Paulo
Country [32] 0 0
Brazil
State/province [32] 0 0
Rio De Janeiro
Country [33] 0 0
Canada
State/province [33] 0 0
Alberta
Country [34] 0 0
Canada
State/province [34] 0 0
British Columbia
Country [35] 0 0
Canada
State/province [35] 0 0
New Brunswick
Country [36] 0 0
Canada
State/province [36] 0 0
Ontario
Country [37] 0 0
Canada
State/province [37] 0 0
Quebec
Country [38] 0 0
Canada
State/province [38] 0 0
Saskatchewan
Country [39] 0 0
Czech Republic
State/province [39] 0 0
Brno
Country [40] 0 0
Czech Republic
State/province [40] 0 0
Hradec Kralove
Country [41] 0 0
Czech Republic
State/province [41] 0 0
Praha 2
Country [42] 0 0
Czech Republic
State/province [42] 0 0
Praha 8
Country [43] 0 0
Finland
State/province [43] 0 0
Turku
Country [44] 0 0
Finland
State/province [44] 0 0
Vaasa
Country [45] 0 0
France
State/province [45] 0 0
Avignon
Country [46] 0 0
France
State/province [46] 0 0
Besancon Cedex
Country [47] 0 0
France
State/province [47] 0 0
Caen
Country [48] 0 0
France
State/province [48] 0 0
Creteil
Country [49] 0 0
France
State/province [49] 0 0
Paris
Country [50] 0 0
France
State/province [50] 0 0
St Genis Laval
Country [51] 0 0
France
State/province [51] 0 0
Strasbourg
Country [52] 0 0
Germany
State/province [52] 0 0
Aachen
Country [53] 0 0
Germany
State/province [53] 0 0
Berlin
Country [54] 0 0
Germany
State/province [54] 0 0
Erlangen
Country [55] 0 0
Germany
State/province [55] 0 0
Essen
Country [56] 0 0
Germany
State/province [56] 0 0
Kirchheim
Country [57] 0 0
Germany
State/province [57] 0 0
Markkleeberg
Country [58] 0 0
Greece
State/province [58] 0 0
Athens
Country [59] 0 0
Hungary
State/province [59] 0 0
Budapest
Country [60] 0 0
Hungary
State/province [60] 0 0
Kecskemet
Country [61] 0 0
Hungary
State/province [61] 0 0
Zalaegerszeg
Country [62] 0 0
India
State/province [62] 0 0
Kerala
Country [63] 0 0
India
State/province [63] 0 0
Maharashtra
Country [64] 0 0
India
State/province [64] 0 0
Ahmedabad
Country [65] 0 0
India
State/province [65] 0 0
Jaipur
Country [66] 0 0
India
State/province [66] 0 0
Kolkata
Country [67] 0 0
India
State/province [67] 0 0
Kolkatta
Country [68] 0 0
Ireland
State/province [68] 0 0
Dublin
Country [69] 0 0
Ireland
State/province [69] 0 0
Cork
Country [70] 0 0
Italy
State/province [70] 0 0
Arezzo
Country [71] 0 0
Italy
State/province [71] 0 0
Genova
Country [72] 0 0
Italy
State/province [72] 0 0
Lecce
Country [73] 0 0
Italy
State/province [73] 0 0
Milan
Country [74] 0 0
Italy
State/province [74] 0 0
Napoli
Country [75] 0 0
Italy
State/province [75] 0 0
Perugia
Country [76] 0 0
Italy
State/province [76] 0 0
Roma
Country [77] 0 0
Korea, Republic of
State/province [77] 0 0
Seoul
Country [78] 0 0
Mexico
State/province [78] 0 0
Baja California
Country [79] 0 0
Mexico
State/province [79] 0 0
Distrito Federal
Country [80] 0 0
Mexico
State/province [80] 0 0
Estado De Mexico
Country [81] 0 0
Mexico
State/province [81] 0 0
Jalisco
Country [82] 0 0
Mexico
State/province [82] 0 0
Nuevo Leon
Country [83] 0 0
Mexico
State/province [83] 0 0
Queretaro
Country [84] 0 0
Norway
State/province [84] 0 0
Stavanger
Country [85] 0 0
Peru
State/province [85] 0 0
Callao
Country [86] 0 0
Peru
State/province [86] 0 0
Lima
Country [87] 0 0
Poland
State/province [87] 0 0
Bialystok
Country [88] 0 0
Poland
State/province [88] 0 0
Lodz
Country [89] 0 0
Poland
State/province [89] 0 0
Warszawa
Country [90] 0 0
Romania
State/province [90] 0 0
Baia Mare
Country [91] 0 0
Romania
State/province [91] 0 0
Cluj Napoca
Country [92] 0 0
Romania
State/province [92] 0 0
Timisoara, Timis
Country [93] 0 0
Russian Federation
State/province [93] 0 0
Moscow
Country [94] 0 0
Russian Federation
State/province [94] 0 0
St Petersburg
Country [95] 0 0
South Africa
State/province [95] 0 0
Free State
Country [96] 0 0
South Africa
State/province [96] 0 0
Gauteng
Country [97] 0 0
Spain
State/province [97] 0 0
Barcelona
Country [98] 0 0
Spain
State/province [98] 0 0
Gijon
Country [99] 0 0
Spain
State/province [99] 0 0
Madrid
Country [100] 0 0
Spain
State/province [100] 0 0
Santander
Country [101] 0 0
Spain
State/province [101] 0 0
Sevilla
Country [102] 0 0
Spain
State/province [102] 0 0
Valencia
Country [103] 0 0
Sweden
State/province [103] 0 0
Kungalv
Country [104] 0 0
Sweden
State/province [104] 0 0
Sundsvall
Country [105] 0 0
Sweden
State/province [105] 0 0
Uppsala
Country [106] 0 0
Sweden
State/province [106] 0 0
Vaxjo
Country [107] 0 0
United Kingdom
State/province [107] 0 0
Glamorgan
Country [108] 0 0
United Kingdom
State/province [108] 0 0
Middlesex
Country [109] 0 0
United Kingdom
State/province [109] 0 0
Surrey
Country [110] 0 0
United Kingdom
State/province [110] 0 0
West Yorkshire
Country [111] 0 0
United Kingdom
State/province [111] 0 0
Essex

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine whether survival can be prolonged in patients with
castration-resistant prostate cancer who receive dasatinib with docetaxel and prednisone.
Trial website
https://clinicaltrials.gov/show/NCT00744497
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications